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by Title ASCRS NEWS Heading Name title Contact Name: email 14 | EYEWORLD | SUMMER 2026 ASCRS FOUNDATION UPDATE XDEMVY® (lotilaner ophthalmic solution) 0.25%, for topical ophthalmic use BRIEF SUMMARY OF PRESCRIBING INFORMATION Please see the XDEMVY® package insert for full Prescribing Information. INDICATIONS AND USAGE XDEMVY is indicated for the treatment of Demodex blepharitis. CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Risk of Contamination Do not allow the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to minimize contamination of the solution. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. Use with Contact Lenses Contact lenses should be removed prior to instillation of XDEMVY and may be reinserted 15 minutes following its administration. ADVERSE REACTIONS Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. XDEMVY was evaluated in 833 patients with Demodex blepharitis in two randomized, double-masked, vehicle- controlled studies (Saturn-1 and Saturn-2) with 42 days of treatment. The most common ocular adverse reaction observed in controlled clinical studies with XDEMVY was instillation site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported in less than 2% of patients were chalazion/ hordeolum and punctate keratitis. USE IN SPECIFIC POPULATIONS Pregnancy: Risk Summary There are no available data on XDEMVY use in pregnant women to inform any drug associated risk; however, systemic exposure to lotilaner from ocular administration is low. In animal reproduction studies, lotilaner did not produce malformations at clinically relevant doses. Data Animal Data In an oral embryofetal developmental study in pregnant rats dosed during organogenesis from gestation days 6-19, increased post-implantation loss, reduced fetal pup weight, and incomplete skeletal ossification were observed at 50 mg/kg/day (approximately 1390 times the recommended human ophthalmic dose (RHOD) on a body surface area basis) in the presence of maternal toxicity (i.e., decreased body weight and food consumption). A rare malformation of situs inversus of the thoracic and abdominal viscera occurred in 1 fetus from a pregnant rat receiving 50 mg/kg/day; whether this finding was treatment-related could not be excluded. No maternal or embryofetal toxicity was observed at 18 mg/kg/day (approximately 501 times the RHOD on a body surface area basis). In an oral embryofetal development study in pregnant rabbits dosed during organogenesis from gestation days 7-19, no embryofetal toxicity or teratogenic findings were observed at 20 mg/kg/day (approximately 580-times the RHOD on an AUC basis), even in the presence of maternal toxicity (i.e., decreased food consumption and body weight). In an oral two-generation reproductive toxicity study, F0 male and female rats were administered lotilaner at doses up to 40 mg/kg/day for 10 weeks before pairing and during the 2-week pairing period (3 weeks for males). Dosing for F0 females continued through lactation day 22. F1 male and female rats were administered lotilaner at 1 and 5 mg/kg/day post-weaning from day 23 for 10 weeks before pairing and during the 2-week pairing period (3 weeks for males). Dosing for F1 parenteral females continued through lactation day 22. There were no clear adverse effects on the F1 generation, and a slightly lower mean body weight during lactation was noted for F2 pups at 5 mg/kg/day. The no observed adverse effect level (NOAEL) was determined to be 5 mg/kg/day (approximately 139 times the RHOD on a body surface area basis). Lactation: Risk Summary There are no data on the presence of XDEMVY in human milk, the effects on the breastfed infant, or the effects on milk production. However, systemic exposure to lotilaner following 6 weeks of topical ocular administration is low and is >99% plasma protein bound, thus it is not known whether measurable levels of lotilaner would be present in maternal milk following topical ocular administration. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for XDEMVY and any potential adverse effects on the breast-fed child from XDEMVY. Pediatric Use: Safety and effectiveness in pediatric patients below the age of 18 years have not been established. Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in animals have not been performed to evaluate the carcinogenic potential of lotilaner. Mutagenesis Lotilaner was not genotoxic in the following assays: Ames assay for bacterial gene mutation, in vitro chromosomal aberration assay in cultured human peripheral blood lymphocytes, and in vivo rat micronucleus test. Impairment of fertility In a two-generation study of reproductive performance in rats, F0 male and female rats were administered lotilaner at oral doses of 40 mg/kg/day for 80 days reduced to 20 mg/kg/day for 47-50 supplementary days. Reduced pregnancy rates and decreased implantation rates were observed in F0 females at doses 20 mg/kg/day) (approximately 556 times the RHOD on a body surface area basis), which were also associated with maternal toxicity (i.e., decreased body weight and food consumption). No effects on fertility were observed in F0 females at the dose of 5 mg/kg/day (approximately 139 times the MRHOD on a body surface area basis). No effects on fertility were observed in F0 males at the oral dose of 20 mg/kg/day (approximately 556 times the RHOD on a body surface area basis), and no effects on fertility were observed in F1 males and females at the oral dose of 5 mg/kg/day (approximately 139 times the RHOD on a body surface area basis). PATIENT COUNSELING INFORMATION Handling the Container Instruct patients to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to minimize contamination of the solution. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. When to Seek Physician Advice Advise patients that if they develop an intercurrent ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician's advice concerning the continued use of XDEMVY. Use with Contact Lenses Advise patients that XDEMVY contains potassium sorbate, which may discolor soft contact lenses. Contact lenses should be removed prior to instillation of XDEMVY and may be reinserted 15 minutes following its administration. Use with Other Ophthalmic Drugs Advise patients that if more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes between applications. Missed Dose Advise patients that if one dose is missed, treatment should continue with the next dose. RX only © 2024 Tarsus Pharmaceuticals, Inc. All rights reserved. XDEMVY is a registered trademark of Tarsus Pharmaceuticals, Inc. US--2300345 1/24 News from the ASCRS Foundation T he ASCRS Foundation hosted a number of events and sessions at the 2026 ASCRS Annual Meeting in Washington, D.C. In addition to recognizing its 2026 award and grant winners, the ASCRS Foundation hosted a symposium, which focused on domestic volunteerism and Operation Sight. The Party for a Purpose was a huge success, raising funds to benefit Operation Sight. The ASCRS Foundation also hosted several events to recognize and thank both individual and industry donors. Operation Sight Volunteer of the Year This year's Operation Sight Volunteer of the Year is Judith Kirby, MD. Dr. Kirby practices at Kirby Eye Center in Dallas, Texas. She spoke to EyeWorld about her involvement with Operation Sight and humanitarian eyecare. Dr. Kirby said that doing volunteer work has been a part of her life since childhood, all the way back to her involvement with Girl Scouts and high school volunteering. When she first finished her ophthalmology training, Dr. Kirby had the desire to get involved with volunteerism and humanitarian eyecare. However, most of the available opportunities were overseas, which was hard for her with small children. "When I became aware of Operation Sight, I was very enthusiastic about it because I could give back to my community without having to leave my family," she said. There is so much conversation about global ophthal- mology needs, but there are significant local ophthalmolo- gy needs as well, she said. It takes very little sacrifice to add an extra surgery at the end of my OR day to take care of a person in need, Dr. Kirby said, adding that ASCRS and Operation Sight have made it easy for her to get involved. "For me, it's ridicu- lously simple," she said. We're talking about people who are usually legally blind because of how bad their cataracts are, she said. They can't work, they can't see their family, and they can't ambulate around their house. Dr. Kirby said that every case where she's able to help patients in need is memorable and impactful. Most of the time, these cataracts are very complex because they have not had the resources previously to obtain eyecare. They start out with such poor vision, so to give that vision back in even just one eye is extraordinary. "The smile on their face is worth everything," she said. "They're so appreciative and so happy. How lucky am I to be able to provide such a service? I feel so fortunate."

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